Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0016
ICR Reference No:
200705-0910-002
Status:
Historical Active
Previous ICR Reference No:
200308-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/17/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/10/2007
Terms of Clearance:
This information collection request is approved. Please note that the burden table has been modified to reflect FDA's email confirming that the changes are a result of adjustment, not program changes. A program change would need to be submitted as a revision, not an extension.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2010
36 Months From Approved
08/31/2007
Responses
12
0
13
Time Burden (Hours)
49,186
0
31,385
Cost Burden (Dollars)
8,200
0
560,000
Abstract:
Please see attached.
Authorizing Statute(s):
US Code:
21 USC 348
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
72 FR 2533
01/19/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 20553
04/25/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504
FDA3504, FDA3503
Color Additive Petition Submission
,
Food Additive Petition Submission
Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
12
13
0
0
-1
0
Annual Time Burden (Hours)
49,186
31,385
0
0
17,801
0
Annual Cost Burden (Dollars)
8,200
560,000
0
0
-551,800
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The change in burden is primarily due to the increase in the estimated hours per response for food additive petitions. The change in cost is actually an increase from the previous approval. The supporting statement requested approval of $5,600 total capital costs but the NOA incorrectly indicates $560,000. For this approval extension request, FDA is estimating a total capital cost of $8,200. The increase of $2,600 reflects one additional category A petition expected to be submitted.
Annual Cost to Federal Government:
$583,100
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
05/10/2007
An official website of the United States government
The .gov means it's official.
The site is secure.
